Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of one single dose of sr58611 compared to placebo and paroxetine

Conditions: Major Depressive Disorders

Summary: primary objective is to demonstrate the antidepressant efficacy on the hamilton depression rating scale (ham-d) of amibegron (sr58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (mdd). secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.


Eligibility criteria:
inclusion criteria: * patients suffering from a recurrent major depressive episode of at least moderate intensity (dsm-iv) * patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months. * the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.

Keywords: depression
intramuscular mononuclear cells and mesenchymal stem cells transplantation to treat chronic critical limb ischemia

Conditions: Critical Limb Ischemia

Summary: this is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow mononuclear cells implantation only in patients with chronic critical limb ischemia. patients will be randomized into two groups of equal number; patients in one group will be implanted with mononuclear cells and mesenchymal stem cells, and the other implanted with mononuclear cells only in the area of affected limb.

when the long blood vessels supplying blood to the arms and legs become blocked (ischemic), patient will experience painful sensations in their calves when they walked which slowly become excruciating painful at rest. when the condition worsens, the patients will not be able to feel any pain from their legs and they will not know if there are any small ulcers or cuts on their legs. as a result, a small ulcer which goes unnoticed becomes bigger and can sometimes become infected. in the worst situations, infection might lead towards gangrene and septicaemia. severe rest pain and/or ulcerations of ischemic limbs are defined as the state of chronic critical limb ischemia and at this point, amputation of the affected limb is suggested. conventional treatments include angioplasty/bypass operation to remove blood vessel blockage to restore blood supply, the use of prescribed medicines to aid in ulcer recovery and clear infection and debridement of damaged/infected tissue. some procedures have to be performed multiple times. amputation is inevitable in many cases because some blood capillaries cannot be corrected and restenosis of vessels is very common. cell therapy with mononuclear cells and mesenchymal stem cells from bone marrow is promising because these stem cells are capable of stimulating and regenerating capillaries and blood vessels.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of critical limb ischemia leading to ischemic ulcers in which amputation is indicated * not suitable for, or remain symptomatic despite angioplasty, bypass operation or collateralization exclusion criteria: * contraindication to epidural anesthesia and bone marrow aspiration * contraindication to contrast angiography * evidence of neoplasia and bone marrow diseases * any acute or chronic communicable diseases including hepatitis b, hepatitis c and hiv * patients with a limited life expectancy (\< 1 year) * patients with myocardial infarction or stroke within 6 months * patients with coronary intervention within 6 months * renal impairment indicated by serum creatinine greater than two times upper limit of the normal range * liver impairment indicated by serum aspartate transaminase and alanine transaminase greater than two times upper limit of normal * any other co-morbidity which the physician deems as a contraindication to stem cell transplantation

Keywords: autologous bone marrow critical limb ischemia efficacy mesenchymal stem cells mononuclear cells
clinical profile and out come of children with wilson's disease

Conditions: Clinical Outcome in WILSON Disease

Summary: clinical profile and out come of children with wilson's disease :a single tertiary center study

wilson disease (wd) is an autosomal-recessive disorder of copper metabolism caused by mutations in the atp7b gene . it presents in childhood, adolescence or adulthood with a wide range of clinical manifestations. the disease prevalence has previously been estimated as 1 in 30,000 , but some recent analyses have suggested a genetic prevalence of 1 in 7,000 . copper is absorbed from the stomach and duodenum, taken up by the liver, and secreted by the liver into the systemic circulation bound to ceruloplasmin atp7b transports copper through the trans-golgi network in hepatocytes before it is incorporated into apoceruloplasmin which is secreted as holoceruloplasmin. atp7b is also essential for biliary excretion of copper when cytoplasmic levels are high. dysfunction of atp7b therefore leads to accumulation of copper in the liver giving rise to cellular damage and disease, and the release of nonceruloplasmin bound copper into the systemic circulation. copper also accumulates and is associated with cellular damage and disease in other organs mostly in the brain typical presentation of wd is in adolescence to early adulthood, but it may occur at any age . clinical presentation can vary widely in terms of type and severity, but the key features are various degrees of liver disease,

Eligibility criteria:
inclusion criteria: * all patients aged 1-18 years * fulfill the criteria for diagnosis of wilson's disease according to wilson's score exclusion criteria: 1. persistent neonatal jaundice. 2. patients presented with acute and chronic liver disease rather than wilson's e.g 1. autoimmune hepatitis 2. hepatitis c virus , 3. hepatitis b virus infection ,(d)hepatic focal lesions and(e) metabolic liver disease e.g gauchier ,glycogen storage disease and niemman pick .
efficacy of pert for pei in unresectable pancreatic cancer.

Conditions: Unresectable Pancreatic Cancer

Summary: - this will a be an open label, multicentre, randomized, controlled study in patients with unresectable pancreatic cancer, locally advanced or metastatic, with significant weight loss, and the tumour located in the head of the pancreas associated with dilated main pancreatic duct. pancreatic exocrine replacement therapy (pert) in these patients will be given on top of other required therapies (best standard of care, bsc), including oncologic therapies, diabetes mellitus therapies and acid suppressants and nutritional support as appropriate. the duration of the study will be up to six months. consecutive patients meeting inclusion criteria and none of the exclusion criteria will be evaluated for the study. those patients signing the informed consent for study participation will be randomized to one of the following two arms: * the experimental arm will receive the best standard of care (bsc) and pert (capsules containing pancreatin 35,000 ph.u.) at a fixed dose of 3 capsules with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months. * the control arm will receive the bsc over 3 months, followed by a further 3-month open uncontrolled phase of bsc + pert at the dose mentioned above. all patients will receive in addition a proton pump inhibitor (ppi) bid (any ppi at standard dose is acceptable -omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, rabeprazole 20 mg, esomeprazole 40 mg) while on pert, 20-30 minutes before breakfast and dinner. to make the two arms comparable, patients will be stratified in two groups (locally advanced and metastatic pancreatic cancer) for randomization using computer generated random numbers.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer. 2. tumour located in the head of the pancreas. 3. dilated main pancreatic duct confirmed by imaging methods (ct scan, mri and/or eus). 4. significant weight loss (≥5% of the usual body weight) at screening. 5. life expectancy of at least six months at screening. 6. signed informed consent to the study. exclusion criteria: 1. hypersensitivity to pancreatin of porcine origin or to any of the excipients. 2. patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned. 3. patients already on pert. 4. prior history of upper gastrointestinal or pancreatic surgery. 5. short life expectancy (shorter than 6 months). 6. patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy). 7. patients in whom a pancreatic stent has been placed. 8. unsolved gastric outlet obstruction. 9. unwillingness to participate in the study. 10. inability to comply with the study visits and study protocol, whatever the reason.
proof-of-concept study with bt063 in subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug bt063 in patients with systemic lupus erythematosus (sle) compared with people who receive a placebo.

study 990 is a phase iia, proof-of-concept study of bt063 in subjects with sle. this study is divided into 2 parts. after part i an interim analysis will be performed. each part will enrol 18 subjects. subjects will be randomly assigned to receive bt063 or placebo 8 times over 12 weeks and will be followed for 4 months after their last dose.

Eligibility criteria:
inclusion criteria: * eligible male and female subjects, age ≥ 18 and ≤ 75 years with body mass index ≥ 18 and ≤ 35 kg/m2 at screening visit * diagnosed sle (defined by ≥ 4 of the 11 american college of rheumatology (acr) classification criteria for sle) for at least 3 months before screening * moderate to severe sle disease activity demonstrated by sledai-2k total score ≥ 6, including skin and joint involvement * clasi activity score ≥ 5 or at least 5 of 66/68 joints with pain and signs of inflammation * positive anti-nuclear antibodies (ana) test at screening * no change in concomitant medication for sle activity maintenance and symptom control regarding type of medication and dose level for at least 8 weeks prior to baseline (for steroids and nsaids/pain medication 2 weeks) * normal electrocardiogram (ecg) exclusion criteria: * active, severe neuropsychiatric sle defined as any neuropsychiatric element scoring bilag level a disease or lupus nephritis * diagnosed psoriasis * presence or history of malignancy within the previous 5 years * systemic antibiotic treatment within 2 weeks before baseline visit * a positive diagnosis for viral hepatitis b or hepatitis c or human immunodeficiency virus (hiv) or tested positive for tuberculosis as assessed or recent infection with herpes zoster or herpes simplex (type 1 and type 2), epstein-barr virus (ebv) or cytomegalovirus (cmv) infection or reactivation at screening * clinically significant hematologic abnormalities attributed to sle: haemoglobin \< 8 g/dl; platelets \< 50 e9/l; leucocytes \< 2.0 e9/l * active or history of inflammatory bowel disease (including active or history of colitis) * received the following medications: - rituximab within the last 48 weeks before screening - belimumab within the last 12 weeks before screening - iv immunoglobulin (ig) within the last 12 weeks before screening - intramuscular (im) or intra-articular glucocorticosteroids within the last 4 weeks before screening - iv cyclophosphamide within the last 6 months before screening - iv glucocorticosteroids (pulse therapy) within the last 6 months before screening * pregnant or nursing women or women who intend to become pregnant * known intolerance to immunoglobulins or comparable substances (e.g., significant vaccination reaction) * known intolerance to proteins of human origin * history of clinically significant drug or alcohol abuse within the last 12 months

Keywords: sle, lupus il10, il-10, bt063, bt-063
physiotherapy and dysfunctional breathing

Conditions: Hyperventilation

Summary: traditionally, the physiotherapy management of people with dysfunctional breathing or hyperventilation syndrome is breathing re-training. there is increasing clinical evidence that structural and functional changes develop in the muscles and connective tissues of the chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over time. when treatment includes breathing techniques only it is difficult for a person with chronic hyperventilation, who has developed muscle and connective tissue changes, to revert to using the normal lower chest diaphragmatic breathing pattern. in clinical practice when the problems which have developed in the musculoskeletal system are addressed, the patient reverts more quickly to the lower chest pattern of breathing but there is as yet little evidence to support this clinical finding.


Eligibility criteria:
inclusion criteria: * diagnosis of dysfunctional breathing (nijmegen score of more than 23) exclusion criteria: * active metastatic disease * osteoporotic disease * dysfunctional breathing as a consequence of respiratory or cardiac disease

Keywords: hyperventilation dysfunctional breathing physiotherapy musculoskeletal techniques
uark 2003-25: a study of intravenous (iv) busulfan (busulfex®) in multiple myeloma patients

Conditions: Multiple Myeloma

Summary: the purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.

this trial will determine the maximal dose of busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are \> or = 65 years of age or have renal insufficiency, defined as creatinine \> 3g/dl or creatinine clearance \< 30 ml/min.

Eligibility criteria:
inclusion criteria: * patients must have symptomatic multiple myeloma requiring treatment * patients must have been approved for single or tandem autologous transplant * patients must be \> or = 65 years of age or diagnosed with renal insufficiency, defined as having a creatinine \> 3 mg/dl or a creatinine clearance \< 30 ml/minute * patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. patients must have adequate pulmonary function studies \> 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) \> 50% of predicted, * patients must have an echo or muga performed within 60 days prior to registration, lvef \> 40%. * bilirubin, sgot, sgpt must be less than 1.5 times the upper limit of normal * patients must have evaluable myeloma marker for response such as: \*serum m protein \>1g/dl or urine m protein \>1g/24 hours and/or; \*bone marrow plasmacytosis with \>20% plasma cells and/or; \*extramedullary plasmacytosis; \*mri/pet scan has focal lesions due to myeloma. * patients must be able to receive full doses of dt-pace, in the opinion of the treating investigator, with the exception of cisplatin. * patients must have a performance status of 0-2 based on swog criteria unless the patient's status is due to active myeloma * all patients must be informed of the investigational nature of the study and have signed an irb-approved informed consent in accordance with institutional and federal guidelines. exclusion criteria: * serum transaminases \> 1.5 x uln and direct bilirubin \> 1.5 mg/dl * hiv positive or active hepatitis b or hepatitis c infection; (if serology is positive a quantitative pcr will be done). * patients with a prior malignancy in whom life expectancy is more likely to be determined by the prior malignancy than the myeloma. patients must not currently be receiving therapy for the prior malignancy. * pregnant or nursing women. women of childbearing potential must have a negative pregnancy test documented within one week of registration. women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

Keywords: myeloma, mm
validation of 'corona-t-test' for assessment of sars-cov-2-specific t-cell response after covid-19 or vaccination

Conditions: SARS-CoV-2 Infection; SARS-CoV-2 Vaccination

Summary: accuracy validation of the designed and manufactured elispot-based in vitro diagnostic 'corona-t-test' for detection of sars-cov-2-specific t cells.

the investigators enrolled three independent cohorts of vaccinated (n = 69), convalescent (n = 50), and healthy but unvaccinated individuals (n = 101). further, they estimated the t cell response to the designed peptide antigen panel, as measured by the manufactured elispot-based in vitro diagnostic 'corona-t-test' to detect sars-cov-2-specific t cells.

Eligibility criteria:
non-specific inclusion criteria * participants aged 18 and above * participants agreeing to follow the study procedures * participants able to understand the purpose, nature, and methodology of the study * participants having signed the informed consent healthy donors inclusion criteria * no self-reported covid-19 infection * no vaccination against covid-19 * no immunoglobulin (ig) igm or igg antibodies against sars-cov-2 by three tests (igm to sars-cov-2 detection: "sars-cov-2-igм-elisa-best", ref #d-5502, igg to sars-cov-2 s protein detection: "sars-cov-2-igg-quantity-elisa-best", "vector-best", ref #d-5505), igg to sars-cov-2 n protein detection: "sars-cov-2 igg reagent kit", architect, abbott laboratories, eu) convalescents inclusion criteria * self-reported covid-19 infection * pcr confirmed covid-19 in a period 14-45 days before recruitment * detectable igg antibodies against sars-cov-2 (igg to rbd domain of sars-cov-2 s protein detection: "sars-cov-2-igg-elisa", "national medical research center for hematology", moscow, russia. ref #k153g) vaccinated inclusion criteria * sars-cov-2 vaccination with 'sputnik v' (gam-covid-vac) in a period 7-14 days after the second vaccination before recruitment * detectable igg antibodies against sars-cov-2 (igg to receptor-binding domain (rbd) domain of sars-cov-2 s protein: "sars-cov-2-igg-elisa", "national medical research center for hematology", moscow, russia. ref #k153g) exclusion criteria - age under 18 y.o.
percutaneous injection plus short segment pedicle screw fixation for traumatic a2 and a3 ao-type fractures in adults

Conditions: Lumbar Fracture; Thoracic Fracture

Summary: the aim of this study was to examine the short- to medium-term efficacy of percutaneous vertebral body reconstruction by vertebral body augmentation with sr-ha paste plus short-segment pedicle screw fixation in fresh fractures, as well as to evaluate sr-ha resorption/substitution. the hypotheses tested in this study were as follows: 1) whether sr-ha is equivalent to pmma for restoring the fractured thoracolumbar vertebral body, 2) whether leakage of sr-ha is less than that of pmma, and 3) whether sr-ha is completely resorbed and replaced by cancellous bone.

introduction polymethacrylate (pmma) is commonly used in vertebroplasty and balloon kyphoplasty, but its use has been associated with complications. this study tests three hypotheses: 1) whether strontium hydroxyapatite (sr-ha) is equivalent to pmma for restoring thoracolumbar vertebral body fractures, 2) if incidence of pmma leakage is similar to that of sr-ha leakage, and 3) whether sr-hais resorbed and substituted by new vertebral bone. materials and methods two age- and sex-matched groups received short percutaneous pedicle screw fixation plus peek implant (kiva, vcf treatment system, benvenue medical, santa clara, ca, usa) filled with either sr-ha (group a) or pmma (group b) after a2- and a3/ao-type thoracolumbar vertebral body fractures. visual analog scale (vas) score and imaging parameters, which included segmental kyphosis angle (ska), vertebral body height ratios (vbhr), spinal canal encroachment (sce), bone cement leakage, and sr-ha resorption, were compared between the two groups.

Eligibility criteria:
inclusion criteria: * one single, severely (\>40%) compressed a2 and a3/ao-type thoracolumbar (t10-l3) fracture * no other serious concomitant injuries exclusion criteria: * polytrauma * neurologic impairment * spinal deformity * known malignancy * previous fracture or surgery in the same or adjacent vertebrae

Keywords: thoracolumbar fractures pmma kiva peek
phase i dose escalation study of bay94-9343 given by intravenous infusion every 3 weeks in japanese subjects with advanced malignancies

Conditions: Neoplasms

Summary: the primary objectives of the phase i study 15404 are to evaluate the safety, tolerability and pharmacokinetics of bay94-9343 given once every 3 weeks in japanese subjects with advanced, refractory solid tumors. the secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.


Eligibility criteria:
inclusion criteria: * japanese subjects ≥ 20 years of age * ecog performance status of 0 to 1 * life expectancy of at least 12 weeks * subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy, have no standard therapy available * subjects whose fresh or archival tumor tissues are available * measurable disease with at least one lesion that can be accurately measured in at least one dimension according to recist criteria (version 1.1 or modified version) * adequate bone marrow, liver, and renal function exclusion criteria: * anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of the first dose * impaired cardiac function or clinically significant cardiac disease (i.e., congestive heart failure (chf) nyha class iii or iv) * myocardial infarction or onset of unstable angina \< 3 months prior to general screening * cardiac arrhythmias in the electrocardiogram that would interfere with qt/qtc interval measurement (lbbb (left bundle branch block), av block, atrial fibrillation) * qtc \>470 ms, derived as the average of the 3 values measured by the ecg recorder's algorithm on the ecg triplicate * lvef (left ventricular ejection fraction) \<50 % * uncontrolled hypertension defined as systolic blood pressure \> 150 mm hg and/or diastolic blood pressure \> 90 mmhg, despite optimal medical management * known human immunodeficiency virus (hiv) infection * subjects with an active hepatitis b or c infection requiring treatment * personal or family history of long qt syndrome (lqts) * subject with clinically significant eye disorders

Keywords: bay 94-9343 anetumab ravtansine adc (antibody drug conjugate) phase i japan solid cancers advanced, refractory solid tumors mesothelin endometrial adenocarcinoma of lung gastrointestinal, ovarian, pancreatic, cholangio, mesothelioma and triple negative breast cancers